Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-B )
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Emergency Stroke Unit based on 0.23-T MRI, Standard stroke unit adherent to guidelines.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Emergency Stroke Unit for Acute Cerebrovascular Events--A Prospective, Multicenter, Week-wise Randomized, Controlled Trial ( ESU-ACE-B )
Overview
To compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) treated in a standard stroke unit adherent to guidelines versus treated in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Detailed description
Mechanical thrombectomy is an effective reperfusion therapy for patients with acute ischemic stroke due to large vessel occlusion. Faster door-to-puncture time (DPT) is associated with significantly better clinical outcomes. With the development of low-field magnetic resonance imaging, it is poised to play an increasingly significant role in the early diagnosis and management of acute ischemic stroke. This prospective, multicenter, week-wise randomized controlled trial will compare the door-to-puncture time of patients with hyperacute ischemic stroke (between 4.5-6 hours after the onset of symptoms) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).
Interventions
- Combination product Emergency Stroke Unit based on 0.23-T MRI
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by Emergency Stroke Unit process based on low-field magnetic resonance imaging. - Combination product Standard stroke unit adherent to guidelines
The participants with hyperacute ischemic stroke (between 4.5-6 hours after onset of symptoms) who are eligible to receive reperfusion therapy will be managed by standard stroke unit process adherent to guidelines.
Primary outcome measures
- Door-to-puncture time [Time frame: Door-to-puncture time]
Secondary outcome measures (12)
- The utility-weighted modified Rankin Scale (uw-mRS) at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Ordinal (shift) analysis of modified Rankin Scale (mRS) at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Good functional outcome (Modified Rankin Scale score, mRS 0-2) at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- The time from symptoms onset to endovascular thrombectomy decision. [Time frame: The time from symptoms onset to endovascular thrombectomy decision.]
- The time from emergency department arrival to endovascular thrombectomy decision. [Time frame: The time from emergency department arrival to endovascular thrombectomy decision.]
- Door-to-reperfusion time [Time frame: Door-to-reperfusion time]
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) within 36 hours. [Time frame: within 36 hours.]
- Symptomatic intracranial hemorrhages (according to the ECASS III criteria) at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Mortality at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Adverse events at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
- Serious adverse events at 14±2 days (or at discharge, whichever occurs first). [Time frame: at 14±2 days (or at discharge, whichever occurs first).]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years;
- Can be treated between 4.5-6 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle);
- Presenting with ischemic stroke symptoms;
- Pre-stroke mRS score 0-1;
- Baseline NIHSS score ≥ 5;
- Eligible for endovascular thrombectomy;
- Informed consent signed.
Exclusion criteria
- Baseline NIHSS score < 5;
- Unable to undergo MRI because of claustrophobia;
- Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
- Definite contraindication for endovascular thrombectomy;
- Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
- Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
- Participation in other interventional randomized clinical trials within 3 months before enrollment;
- Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06492265 · KY2024-131-02-B